Indicating device

ABSTRACT

An indicating device for indicating the number of metered doses of medicaments that have been dispensed from or remain in a container having a valve stem extending longitudinally therefrom and moveable between an open and closed position. The indicating device includes a base member adapted to be mounted to the container, a cap member moveably connected to the base member, one or more indicator members rotatably mounted to the cap member and an indicating mechanism adapted to rotate the indicator member an incremental amount upon a predetermined number of axial movements of the cap member relative to the base member. A preferred embodiment of the indicating device includes a ratchet wheel, a drive member selectively engaging the indicating member, a pawl selectively engaging the ratchet wheel, and a non-return member adapted to selectively engage the ratchet wheel so as to maintain a unidirectional rotation of the ratchet wheel. In one embodiment, the indicating device also includes a usage indicator member having usage indicia that indicates the number of usage cycles completed or remaining for the indicating device. A method for indicating the number of metered doses dispensed from or remaining in the container comprises moving the cap member toward and away from the base member, engaging the ratchet wheel with the pawl and engaging the indicating member with the drive member. A method of assembling an inhalation device including an indicating device is also provided.

BACKGROUND OF THE INVENTION

[0001] The present invention relates generally to an indicating devicefor indicating the number of metered dosages that have been dispensedfrom, or remain in, an aerosol container, and in particular, to anindicating device adapted to be mounted to the aerosol container.

[0002] Aerosol dispensing devices have been developed that include adose indicating device to indicate the number of metered doses that havebeen dispensed from the device, or to indicate the number of dosesremaining therein. For example, patients have certain conditions thatcan be treated with medicaments dispensed in an aerosol and administeredto the patient by inhalation. In one format, the aerosol withmedicaments are contained in a container, and dispensed in metered, ormeasured, dosages with an inhalation device, or actuator boot. In suchan arrangement, it can be important for the patient to be able toascertain the number of metered doses remaining in the container, eitherby an indication of the number remaining therein or by knowledge of thenumber already dispensed therefrom, such that the patient is not caughtunaware with an empty container when in need of the medicament. Thus, itmay be important for the inhalation device to provide an accurateindication of either the number of doses remaining in the container, orthe number of doses already dispensed therefrom.

[0003] Typically, a conventional aerosol container includes a body and avalve stem which can be depressed relative to the body so as to emit themetered dose of aerosol and medicament. The container typically issupplied with a predetermined number of metered doses, generally on theorder of about 200, such that the counting of the number of valve stemdepressions, and corresponding number of dispensed metered doses, can bedirectly correlated with the number of doses remaining in the container.

[0004] In operation, the container is typically received within ahousing of the inhalation device, wherein the valve is brought intoengagement with a support block in the housing. The user administers themedicament by moving the container relative to the housing so as todepress the valve stem and internal valve and thereby release a metereddose, which is typically administered to the user through a port ormouthpiece extending from the housing. After the dose is administered,the valve stem, which is typically spring loaded, biases the containeraway from the support block so as to again move the container relativeto the housing. In this way, a metered dose of medicament isadministered by each cycle of linear reciprocal movement of thecontainer relative to the housing.

[0005] Some actuator boots, or other devices attached to the medicamentcontainer, have indicating devices that convert the linear reciprocalmovement of the container relative to the housing into a one-way, orsingle-cycle, movement of an indicator, wherein the indicator identifiesthe relative fullness of the container, the number of metered dosesremaining therein or the number of doses already administered. Althoughthese actuator boots with indicators, or separate indicator devices,have provided the advantage of generally being able to keep track of thenumber of dosages, there remains room for improvement. For example,indicating devices of this nature may include complex moving parts whichcan be difficult to assemble and expensive to manufacture. Such devicesmay also be susceptible to counting inaccuracies due to theconfiguration of the indexing or mating parts, or require excessiveamounts of space within the housing to accommodate the relatively largeor numerous moving parts. Others still may impede or interfere with theairflow and medicament being dispensed from the inhalation device.Alternatively, some devices use electrical circuitry to count or recordthe dispersements. Such devices can be relatively expensive tomanufacture, however, and typically require a power source which may besusceptible to damage in various environments, such as moist conditions.

SUMMARY OF THE INVENTION

[0006] Briefly stated, the invention is directed to an indicating devicefor indicating the number of metered doses that have been dispensed fromor remain in a container. The container has a valve stem extendinglongitudinally therefrom; the valve stem being moveable between a closedposition and an open position. The container dispenses a metered dosagewhen the valve stem is moved to the open position. The indicating deviceincludes a base member adapted to be mounted to the container, a capmember moveably connected to the base member, an indicator memberrotatably mounted to the cap member and a drive member adapted to rotatethe indicator member an incremental amount upon a predetermined numberof axial movements of the cap member relative to the base member.

[0007] In a preferred embodiment, the cap member is moveable relative tothe base member along an axial path. The indicator member has aplurality of teeth and is rotatably mounted to the cap member about anaxis substantially parallel to the axial movement of the cap memberrelative to the base member. A drive mechanism, including the drivemember, comprises a ratchet wheel rotatably mounted to one of the basemember and cap member about an axis substantially perpendicular to theaxis defined by the axial movement of the cap member relative to thebase member. The drive member is coaxially mounted with the ratchetwheel and a pawl is mounted to one of the cap member and base member.The pawl is selectively engaged with the ratchet wheel upon each axialmovement of the cap member relative to the base member so as to rotatethe ratchet wheel and drive member an incremental amount. The drivemember is selectively engaged with at least one of the plurality ofindicator member teeth upon a predetermined number of axial movements ofthe cap member relative to the base member such that the indicatormember is rotated an incremental amount.

[0008] In another aspect, the indicating device comprises a first andsecond indicator member, with each of the first and second indicatormembers mounted to the cap member about an axis substantially parallelto the axial movement of the cap member relative to the base member. Thefirst indicator member selectively engages the second indicator memberas the first indicator member completes a usage cycle, representing onecomplete use of the indicating device and attached container, so as torotate the second indicator member an incremental amount. In a preferredembodiment, the first indicator member comprises dosage indiciaindicating the number of doses that have been dispensed from or remainin the container, while the second indicator member comprises usageindicia indicating the number of usage cycles that have been completedfor the indicating device, or the number of usage cycles remainingtherefor.

[0009] In yet another aspect, the indicating device comprises a firstindicator mounted to the cap member about an axis substantially parallelto the axial movement of the cap member relative to the base member anda second indicator member mounted to one of the cap member and the basemember about an axis substantially perpendicular to the axial movementof the cap member relative to the base member. In a preferredembodiment, both the first and second indicator members comprise dosageindicia indicating the number of doses that have been dispensed from orremain in the container, with the second indicator member rotating anincremental amount in response to each axial movement of the cap memberrelative to the base member and the second indicator member rotating anincremental amount upon a predetermined number of axial movements of thecap member relative to the base member.

[0010] In another aspect, the indicating device comprises a first andsecond indicator member mounted to the cap member about an axissubstantially parallel to the axial movement of the cap member relativeto the base member and a third indicator member mounted to the capmember about an axis substantially perpendicular to the axial movementof the cap member relative to the base member. In a preferredembodiment, the first and third indicator members comprise dosageindicia, while the second indicator member preferably comprises usageindicia.

[0011] In yet another aspect, the indicating device comprises a resetmember connected to one of the drive member and indicator member. Thereset member can be rotated to move the indicator member relative to thecap member independent of any axial movement of the cap member relativeto the base member.

[0012] In another aspect of the invention, a method is provided forindicating the number of measured dosages dispensed from or remaining inthe container. The method includes the steps of providing a housing formoveably supporting the container and providing an indicating devicehaving a cap member, a base member and an indicator member rotatablymounted to the cap member. The method further comprises the steps ofmoving the cap member toward the base member so as to move the containeralong the longitudinal axis and thereby move the valve stem to the openposition wherein a metered dosage is discharged, moving the cap memberaway from the base member, and moving the indicator member in responseto the movement of the cap member relative to the base member.

[0013] Referring to a preferred embodiment, the method further includesthe steps of engaging the ratchet wheel with the pawl upon one of themovements of the cap member toward and away from the base member andengaging the indicator member with the drive member so as to rotate theindicator member.

[0014] In yet another aspect, a method is provided for assembling adispenser for dispensing metered dosages of medicaments from acontainer. The method includes the steps of providing a housing,disposing a container in the housing and mounting an indicating deviceto the container.

[0015] The present invention provides significant advantages over otheraerosol dispensing devices and indicating devices used therewith. Inparticular, the indicating device can be separately manufactured andinstalled as needed on any number of conventional types of aerosolcontainers with little or no required modification to the container orhousing. Moreover, the indicating device with its indicator member anddrive mechanism is comprised of a relatively few, simple mechanicalparts that are relatively easy to manufacture and assemble. In this way,the indicating device is made more robust and is less susceptible todamage when exposed to various adverse user environments. In addition,the drive mechanism and indicator member provide a reliable indicatingdevice for indicating the number of doses dispensed from or remaining inthe container, and the indicating device can be made in a relativelycompact configuration that does not interfere with the use of thedispensing device.

[0016] The present invention, together with further objects andadvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1 is a top view of an indicating device having a viewingwindow.

[0018]FIG. 1A is a top view of the indicating device showing analternative embodiment of the viewing window with indicia visibletherethrough.

[0019]FIG. 1B is a top view of the indicating device showing analternative embodiment of the indicia.

[0020]FIG. 2 is a side view of the indicating device being mounted tothe top of a container shown in cross-section.

[0021]FIG. 3 is a top perspective view of the indicating device with theviewing window positioned in the top of the cap member.

[0022]FIG. 3A is a top perspective view of the indicating device withthe viewing window positioned along a side portion of the cap member.

[0023]FIG. 4 is a bottom perspective view of the cap member with theindicator member mounted therein.

[0024]FIG. 5 is an exploded perspective view of the cap member andindicator member shown in FIG. 4.

[0025]FIG. 6 is an exploded perspective view of an alternativeembodiment of the indicating device, including a base member, a capmember, an indicator member, a ratchet wheel and drive member and aspring.

[0026]FIG. 7 is a bottom perspective view of the cap member andindicator member of FIG. 6, with the indicator member mounted in the capmember.

[0027]FIG. 8 is an enlarged partial view of the indicator member and capmember of FIG. 7 showing an engagement of the indicator member by thecap member.

[0028]FIG. 9 is a bottom perspective assembly view of the cap member,indicator member, ratchet wheel, drive member and spring shown in FIG.6.

[0029]FIG. 10 is an exploded perspective view of the base member and thecap member with the drive mechanism and indicator member mountedtherein.

[0030]FIG. 11 is a perspective assembly view of the indicating deviceshown in FIG. 10.

[0031]FIG. 12 is a cross-sectional view of the indicating device takenalong line 12-12 of FIG. 11, wherein the cap member is in a fullyextended position relative to the base member prior to the applicationof an axial force by the user.

[0032]FIG. 13 is a cross-sectional view of the indicating device similarto FIG. 12 but with the cap member shown as moving toward the basemember at an intermediate position of the stroke as indicated by thedirectional arrows.

[0033]FIG. 14 is a cross-sectional view of the indicating device similarto FIG. 12 but with the cap member reaching the bottom of the stroke asindicated by the directional arrows.

[0034]FIG. 15 is a cross-sectional view of the indicating device similarto FIG. 12 showing the cap member as it returns to the fully extendedposition relative to said base member as indicated by the directionalarrows.

[0035]FIG. 16 is a cross-sectional view of the indicating device takenthrough the middle of the indicating device and showing engagementmembers disposed in pockets formed in the base member.

[0036]FIG. 17 is a cross-sectional view of the indicating device takenthrough the middle of the indicating device and showing an alternativereturn mechanism for the cap member.

[0037]FIG. 18 is a bottom view of the assembly of FIG. 9 (without thespring) at initial setting before a first actuation of the indicatordevice and container.

[0038]FIG. 19 is a cross-sectional view taken along line 19-19 of FIG.18.

[0039]FIG. 20 is a bottom view of the assembly of FIG. 9 (without thespring) after the ratchet wheel and drive member have completed onerevolution corresponding to a predetermined number of actuations.

[0040]FIG. 21 is a cross-sectional view taken along line 21-21 of FIG.20.

[0041]FIG. 22 is an enlarged partial bottom view of the cap member andindicator member showing the indicator member having an indexing memberengaging an indentation formed on the cap member.

[0042]FIG. 23 is a side view of an alternative embodiment of theindicating device.

[0043]FIG. 24 is a top view of the indicating device shown in FIG. 23.

[0044]FIG. 25 is a cross-section view of the indicating device takenalong line 25-25 of FIG. 24.

[0045]FIG. 26 is a cross-section view of the indicating device takenalong line 26-26 of FIG. 23.

[0046]FIG. 27 is a perspective view of an indicating device with a resetdevice.

[0047]FIG. 28 is a perspective view of an indicating device with analternative embodiment of the reset device.

[0048]FIG. 29 is an exploded view of an alternative embodiment of theindicating device with an alternative embodiment of the reset device andan adapter.

[0049]FIG. 30 is a bottom perspective view of the indicating device andadapter shown in FIG. 29.

[0050]FIG. 31 is an exploded side view of an indicating device andadapter being applied to the bottom of a container supported in adispenser housing shown in cross-section.

[0051]FIG. 32 is a side view of an indicating device having an adapterapplied to the bottom of a container supported in a dispenser housingshown in cross-section.

[0052]FIG. 33 is a side view of the indicator member and a lock memberin a disengaged position.

[0053]FIG. 34 is a bottom view of the indicator member and lock membershown in FIG. 33.

[0054]FIG. 35 is a side view of the indicator member and lock member inan engaged position.

[0055]FIG. 36 is a bottom view of the indicator member and lock membershown in FIG. 35.

[0056]FIG. 37 is a perspective view of an alternative embodiment of anindicating device having at least one indicator member with dosageindicia and an indicator member with usage indicia.

[0057]FIG. 38 is an exploded perspective view of the indicating deviceshown in FIG. 37.

[0058]FIG. 39 is a bottom perspective view of the cap member shown inFIG. 38.

[0059]FIG. 40 is a bottom perspective view of a dosage indicator membershown in FIG. 38.

[0060]FIG. 41 is a top perspective view of a usage indicator membershown in FIG. 38.

[0061]FIG. 42 is a perspective view of a drive assembly and dosageindicator member shown in FIG. 38.

[0062]FIG. 43 is a perspective view of the reset member shown in theindicating device shown in FIG. 38.

[0063]FIG. 44 is an exploded perspective view of an alternativeembodiment of an indicating device having indicator members with dosageindicia and an indicator member with usage indicia.

[0064]FIG. 45 is a bottom perspective view of the cap member shown inFIG. 44 with a usage indicator member installed therein and a dosageindicator member exploded out therefrom.

[0065]FIG. 46 is a bottom perspective view of a dosage indicator membershown in FIG. 44.

[0066]FIG. 47 is a perspective view of a reset assembly shown in FIG.44.

[0067]FIG. 48 is a perspective view of the drive member shown in FIG.44.

[0068]FIG. 49 is a bottom perspective view of the usage indicator membershown in FIG. 44.

[0069]FIG. 50 is a top perspective view of the usage indicator membershown in FIG. 44.

[0070]FIG. 51 is a bottom perspective view of the cap member shown inFIG. 44.

[0071]FIG. 52 is a cut-away perspective view of the reset member shownin FIG. 44 with the drive member in a disengaged position.

[0072]FIG. 53 is a cut-away perspective view of the reset member shownin FIG. 44 with the drive member in the engaged reset position.

[0073]FIG. 54 is a side view of a first and second dosage indicatormember with the reset member and drive member in a disengaged position.

[0074]FIG. 55 is a side view of a first and second dosage indicatormember with the reset member and drive member in an engaged resetposition.

[0075]FIG. 56 is a top perspective view of a first and second dosageindicator member, a usage indicator member and a drive assembly.

[0076]FIG. 57 is a bottom perspective view of the base member shown inFIG. 38.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

[0077] Referring to the drawings, and in particular FIGS. 31 and 32, anaerosol dispenser is shown as including a housing 200, or actuator boot,and a container 12 disposed therein. The housing has a longitudinallyextending cavity 202 shaped to receive the container. A top portion ofthe housing is generally open such that the container can be inserted inthe housing through opening 204 and be installed therein with a bottomend 14 of the container protruding from the housing so as to be exposedto the user for actuation.

[0078] The terms “longitudinal” and “axial” as used herein are intendedto indicate the direction of the reciprocal movement of the containerrelative to the housing, and of an indicating device cap member relativeto a base member. The terms “top,” “bottom,” “upwardly” and “downwardly”are intended to indicate directions when viewing the inhalation devicesas shown in the Figures, but with the understanding that the containeris inverted such that the top surface thereof is located adjacent thebottom of the housing and vice versa. Moreover, it should be understoodthat a user can use the container and dispenser in any number ofpositions, including but not limited to the preferred upright positionshown in FIGS. 31 and 32.

[0079] As shown in FIGS. 31 and 32, a cylindrical support block 212having a well 214 is formed in a bottom portion 206 of the housing. Anorifice 210 penetrates the support block to communicate with a bottomportion of the well. In one embodiment, a mouthpiece 208, intended forinsertion into the mouth of a patient, forms an exhaust port 216 thatcommunicates with the orifice and well. The mouthpiece 208 extendslaterally from the housing so as to facilitate insertion of themouthpiece into the mouth of the patient.

[0080] The container 12 is cylindrical and has a hub 16 disposed on atop surface 17 thereof. A valve stem 18 extends longitudinally from thehub. The valve stem extends coaxially from the container and is biasedoutwardly therefrom by a spring (not shown) mounted within the valvestem of the container. The container 12 is mounted in the housing bypress fitting the valve stem 18 in the well 214 of the support block.

[0081] In a preferred embodiment, the container 12 is filled with apressurized aerosol and medicament which is dispensed therefrom inspecific metered doses by depressing or moving the valve stem 18 from anextended closed position to a depressed open position. A single metereddose is dispensed from the container by each reciprocal, longitudinalmovement of the valve stem.

[0082] In operation, the opening of the valve stem is effected by movingthe container 12 reciprocally within the housing 200 along alongitudinal axis, defined by the valve stem and the reciprocal movementof the container, by depressing the bottom end 14 of the containerrelative to the housing so as to move the valve stem 18 to the openposition as it is supported within the well by the support block. As thevalve stem is moved to the open position, the container dispenses ametered dose of aerosol and medicament through the well 214 and orifice210. The aerosol and medicament are then transmitted to the patientthrough the exhaust port 216 of the mouthpiece by way of either aself-generated or assisted airflow.

[0083] In other delivery systems, the housing and holder for thecontainer are attached to a component having a chamber with an outputend. Examples of these kinds of delivery systems are shown for examplein U.S. Pat. No. 5,012,803, issued May 7, 1991, and U.S. Pat. No.4,460,412, issued Sep. 11, 1984, both of which are hereby incorporatedherein by reference. (No license, expressed or implied, is intended tobe granted to either of these patents by reason of the incorporation byreference herein). In these kinds of delivery systems, the componenthaving the chamber can be adapted to receive the mouthpiece of thehousing, or it can be integrally connected with a holder supporting thecontainer. In either embodiment, the metered dose of medicament inaerosol is first dispensed from the container into the chamber, andthereafter inhaled by the patient.

[0084] In a preferred embodiment, the container 12 is intended todispense a predetermined number of metered doses of medicament. Forexample, conventional inhaler containers typically hold on the order of100 to 200 metered doses. It should be understood, however, that therange of available doses could potentially vary from as few as one doseto as many as 500, or even more, depending, for example, on the capacityof the container, and/or the size of the metering dose valve. Inoperation, it can be important for the patient to be aware of the numberof metered doses remaining in the container such that the patient is notcaught unaware with an empty container when in need of the medicament.

[0085] Now generally referring to the Figures, a dose indicating deviceis shown. The indicating device 10 indicates the number of metered dosesthat have been dispensed from or remain in the container. As shown inthe embodiments of FIGS. 1-3A and 10-11, respectively, the indicatingdevice 10, 200, 500 includes an indicating device housing comprised of acap member 20, 220, 520 disposed in a base member 40, 540. The basemember 40 is configured such that it can be mounted to the bottom of thecontainer 12. In a first embodiment, shown in FIGS. 2, 6 and 12-17, thebase member includes a convex, or curved bottom portion 50, or floor,which is shaped to be received in and to mate with the bottom end 14 ofthe container, which has a concave or inwardly curved contour (see FIG.2). The base member 40 is preferably bonded to the bottom of thecontainer with adhesive, double sided tape, or similar bonding agent. Asshown in FIGS. 6 and 10-15, a circumferential skirt member 94 extendsupwardly from the base portion to form a cavity 96.

[0086] Alternatively, as shown in FIG. 25, the base member 140 includesa bottom portion 150, a downwardly depending circumferential skirt 152and an upwardly depending circumferential skirt 156. Depending skirt 152forms a recess or cavity 154 which is shaped to receive the bottom endof the container. The base member is mounted on the container either bybonding one or more of the bottom portion or skirt to the container, orby press fitting the container in the cavity 154 so as to provide aninterference fit between the container and the depending skirt. Theupwardly depending skirt 156 and bottom portion form an upper cavity 158overlying the lower cavity 154.

[0087] In yet another embodiment, shown in FIGS. 29-32, an adaptermember 90 is attached to one of the above-mentioned base members by wayof bonding, an interference fit, a snap fit, or a threadable engagement.The adapter member 90 preferably has a cylindrical configuration andcomprises a circumferential skirt 92 that is shaped to receive thebottom end of the container. Again, the adapter can be mounted to thecontainer by way of bonding, an interference fit, or both. Adaptershaving different internal diameters can be provided such that a singleindicating device having a modular base member can be mounted on variousaerosol containers having a variety of outer diameters.

[0088] Alternatively, as shown in FIG. 57, the base member 1040 includesa downwardly depending circumferential skirt 1152 forming a recess 1154.The skirt 1152 includes one or more steps 1155 or shoulders, which formvarious inner diameters in the base member 1040. In this way, a singlebase member 1040 can be used with containers having different diameters.It should be understood that although only one step is shown, so as tothereby form two inner diameters on the skirt 1152, the base membercould be configured with additional steps so as to provide a pluralityof various inner diameters dimensioned to receive various containers byway of a friction fit. The skirt 1152 is also configured with aplurality of cut-outs, or slits 1153, which permit enhanced air flowaround the base member in embodiments where the base member may be inclose proximity to the area where the medicament or aerosol is beingdispensed.

[0089] Although the disclosed container and indicating device, and inparticular, the cap member and base member, are shown as preferablyhaving a circular cross section, those skilled in the art shouldunderstand that the container and indicating device, including anyadapter, can be configured in other shapes, including for example, butnot limited to, a rectangular or triangular cross-section.

[0090] As best shown in FIGS. 1, 1A and 1B, the cap member 20 has a topportion 52 with a viewing window 34, 59 formed therein. Preferably, thecap member 20 is circular and the viewing window is formed in the topportion adjacent the outer periphery of the cap member so as to overlieindicia applied to the top of an indicator member supported beneath thecap member. The viewing window can be configured in a number of variousshapes. For example, the viewing window 34 can be tapered as shown inFIG. 1, or it can be an arcuate shaped window 59 bounded by coaxialinner and outer curved borders 57, 58 and radial side borders 56 asshown in FIGS. 1A and 1B . The top of the cap member preferably has aplurality of raised portions 54 forming a grippable pattern for theuser's thumb, or finger. In this way, the user can firmly press down onthe cap member without slippage. One of skill in the art shouldrecognize that other patterns or grippable surfaces, such as a knurledpattern, can be applied to the cap member to facilitate the use of theindicating device.

[0091] Referring to FIGS. 4, 6, 38 and 44 the cap member 20, 220,1020,2020 comprises a circumferential skirt 92, 292,1092, 2092 dependingdownwardly from the top portion 52, 252,1052, 2052. The skirt preferablyhas a smaller diameter than the upwardly depending skirt of the basemember, such that the cap member skirt nests within the upwardlyextending skirt of the base member. Alternatively, the cap member can beconfigured with a skirt having a larger diameter than the skirt of thebase member such that the base member skirt nests in the cap memberskirt. The cap member 20, 220, 1052, 2052 is moveably mounted to thebase member 40, 1040, 2040 by way of a snap fit.

[0092] In particular, as shown in FIGS. 5, 6, 7, 9, 10, 16, and 44 thecap member includes a plurality of engagement members 28, 228 extendingfrom an outer circumferential surface of the skirt. The cap member isinserted axially within the recess or cavity 96 of the base member suchthat the engagement members 28, 228, which have a tapered surface, slidepast the rim 42 of the base member skirt until the engagement membersare disposed in a plurality of pockets 43 formed along the innercircumferential surface of the base member skirt to form a snap-lockfit. In particular, the upper surface of the engagement member engagesan engagement surface 45 defining the top of the pocket. In this way,the cap member is moveable with respect to the base member along anaxial, or longitudinal, path. Alternatively, the rim of the base membercan be curved slightly inward such that the engagement members engagethe inwardly curved rim portion so as to prevent the cap member frombeing separated from the base member.

[0093] The axial movement of the cap member 20, 220, 1020, 2020 relativeto the base member 40 is bounded or constrained by the engagement of theengagement members with the top of the base member pockets (or the basemember rim) at a fully extended position and by engagement of a bottomrim 21, 221,1021, 2021 of the cap member skirt with the upper surface ofthe bottom portion at the bottom of the stroke as shown for example inFIGS. 12-15. One of skill in the art should understand that theengagement members can alternatively be formed on the base member skirtso as to engage pockets or openings, or a rim (or like protrusion),formed on the cap member skirt.

[0094] As shown in FIGS. 6, 9, 16 and 17, a spring 100 is disposedbetween the cap member and the base member. The spring is preferablydisposed in a downwardly extending hub portion 30, 230 of the cap member(shown in FIGS. 4 and 6) and an upwardly extending hub portion 44 (shownin FIGS. 10, 16 and 17) of the base member, which are received one inthe other. Alternatively, as shown in FIG. 25, a spring 300 is disposedbetween the cap member and base member and is of such a size that thecoils are positioned adjacent the inner circumferential surface of thecap member skirt 392. The spring 100, 300 functions as a returnmechanism and biases the cap member 60, 260, 360 upwardly in the basemember such that the engagement members 28, 228 of the cap member engagethe upper portion of the pockets of the base member. Although acompression spring is shown in the Figures, it should be understood thata belleville washer, cantilever, torsion, leaf and/or tension springswould also work to bias the cap member upwardly into engagement with thebase member. The springs can be made of metal or plastic.

[0095] As shown in FIGS. 4, 5, 16, 17 and 45, the return mechanismacting between the cap member and base member includes a plurality ofresilient arm members 400, 2400 extending downwardly from the capmember. As the cap member is moved toward the base member, one or moreof the arm members engages a ramped biasing surface 402 formed along anouter portion of the hub portion 44. The ramped biasing surface biasesone or more of the resilient arm members outwardly as the cap membermoves toward the base member. As shown in the embodiment of FIGS. 4 and5, six arm members 400 are arranged circumferentially around the hubportion 30. Alternatively, as shown in the embodiment of FIG. 39, sixarm members 1400 are arranged in an “X” pattern around the hub 1030 soas to conserve space and provide additional room under the cap member1020. Corresponding ramps, or ramped biasing surfaces are similarlyarranged in the base member 1140.

[0096] The resilient arm member(s) act as cantilever springs to bias thecap member away from the base member when the cap member is released bythe user. One of skill in the art should understand that the resilientarm members can also be formed on the base member so as to engage aramped surface formed on the cap member. One of skill in the art shouldalso understand that the spring and resilient arm members can be usedtogether, as shown in FIGS. 16 and 17, or separately. In addition, itshould be understood that one or more arm members and/or ramps may beused, with the size and shape of the arm member and/or ramp membersbeing modified to provide more space between the cap member and basemember.

[0097] As shown in FIGS. 4, 6, and 44 a key member 32, 232, or alignmentrib, extends radially from the cap member hub portion 30, 230. As shownin FIG. 10, a key hole 47, or slot, is formed in a radially extendingportion of the hub portion 44 of the base member. The slot extendsradially from the opening in the hub portion. During assembly, the keymember of the cap member is received in the key hole of the base memberso as to prevent rotation therebetween.

[0098] Referring to the various embodiments of FIGS. 4-9, 12-15, 38,40,and 44-46, a dosage indicator member 60, 260,1060, 2060 is rotatablymounted in the cap member 20, 220,1020, 2020 about an axis substantiallyparallel to the axial movement of the cap member relative to the basemember. The indicator member is generally open in the middle andincludes a top portion 76, 276, 1076, 2076 having an upper surface thatrotatably slides along a bottom surface of the top portion of the capmember. Alternatively, the indicator member can be mounted on theoutside of the cap member with a viewing window formed in the indicatormember for viewing indicia applied to the top of the cap member.

[0099] As shown in the embodiments of FIGS. 5, 6, 38 and 44, theindicator member 60, 260,1060, 2060 includes a circumferential skirt 74,274,1074, 2074 depending downwardly from the top portion. Referring toFIGS. 5 and 8, a plurality of protrusions 26, 226, or engagement tabmembers, extend from an inner circumferential surface of the cap memberskirt and engage a rim 64, 264 formed on the bottom of the indicatormember skirt. Alternatively, the indicator member can include anengagement member, or rim, that engages a groove or similar opening inthe cap member. In this way, the indicator member is secured to the capmember so as to prevent axial movement therebetween but where theindicator member is permitted to rotate relative to the cap member. Theindicator member is installed by snap-fitting the indicator memberwithin the cap member. One of skill in the art should understand thatthe indicator member could alternatively be rotatably mounted on the capmember hub portion (having a portion of the key member cut away), or ona similar axle secured to the cap member.

[0100] In yet another alternative embodiment, shown in FIGS. 25 and 26,a plate member 380 holds the indicator member 360 against the innersurface of the top portion of the cap member, wherein the spring 300engages a bottom surface of the plate member 380 to bias a top portion398 of the plate member against the cap member and the cap member awayfrom the base member. The indicator member 360 is nested in the recessformed between an outer flat portion of the plate member and the bottomsurface of the cap member. Referring to FIG. 26, the drive assembly ismounted to the plate member 380 by inserting axle 384 through openingsin downwardly extending walls 388 of the plate member. An enlargedportion 396 on the end of the axle engages one of the walls, while theratchet wheel 382 and drive member 386 are mounted to the other end ofthe axle to complete the assembly. A top portion of the plate memberabuts the cap member.

[0101] As shown in the embodiments of FIGS. 4-9, 40 and 46 the indicatormember 60, 260, 1060, 2060 has a plurality of inwardly facing teeth 66,266, 1066, 2066 formed around the inner circumference of the skirt. Asshown in FIGS. 5, 6, and 40, the teeth are preferably formed about onlya portion of the circumference, such that a gap 1061 is formedtherebetween.

[0102] Alternatively, as shown in the embodiment of FIG. 24, theindicator member 360 has a plurality of teeth 366 formed radiallyinwardly about an inner rim of an opening formed in the indicatormember, which is configured as a relatively flat ring that does notinclude a skirt. In yet another embodiment, shown in FIG. 25, theplurality of teeth 466 extend axially downwardly from a ring-likeindicator member 460.

[0103] As shown in the embodiments of FIGS. 5 and 44-46, the indicatormember 60, 2060 includes a plurality of indentations 68, 2068 formedabout the outer circumferential surface of the skirt 74, 2074. The capmember includes a pair of upwardly extending resilient indexing members22, 2022 each having an end portion that engages one of the indentationsso as to releasably engage the indicator member and prevent rotationtherebetween. The angular distance between the indentations 68, 2068 issubstantially the same as the angular distance between the plurality ofindicator member teeth 66, 2066. In this way, the indexing memberselectively engages the next indentation upon each incrementaladvancement of the indicator member defined by the distance betweenadjacent teeth. In the embodiment shown in FIG. 46, the indentations arepreferably formed as ratchet teeth which only permit one-way rotation ofthe indicator member 2060 relative to the cap member.

[0104] Alternatively, as shown in the embodiments of FIGS. 6 and 38-39,the indentations and indexing member are reversed, i.e., theindentations 224, 1224 are formed about an inner circumferential surfaceof the cap member skirt and, and shown in FIG. 6, an indexing member 270depends downwardly from the indicator member in a void formed in theskirt of the indicator member, or, as shown in FIG. 38, a pair of indexmembers 1270 are configured as flexible arms formed along a rim portion1078 along the bottom edge of the skirt 1074. In the embodiment shown inFIGS. 38, 39 and 40, the interaction between the index members 1270 andthe indentations 1224, which are preferably shaped as ratchet teeth,function to index the indicator member by holding it in place betweenactuations of the cap member and also to prevent the backward rotationof the indicator member 1060. It should be understood that one or moreindex members can be engaged with a plurality of indentations,preferably formed as ratchet teeth, to control the rotational movementof the indicator member, regardless of whether the index members orindentations are formed on the cap member or the indicator member.

[0105] In yet another alternative, shown in FIG. 26, the plate member380 includes a resilient indexing member 370 that engages one of theplurality of teeth 366 to selectively engage the indicator member so asto prevent the inadvertent rotation thereof. Alternatively, the indexingmember can extend from the cap member.

[0106] As shown in FIGS. 1A and 1B, dosage indicia 72, 172 in the formof numbers or color codings are provided on the top surface of theindicator member and are visible to the user through the viewing window34, 59 provided in the top of the cap member. Alternatively, as shown inthe embodiment of FIGS. 24 and 26, a zero is positioned adjacent arectangular viewing window 334, preferably by permanent etching, toindicate a multiplication by ten of the indicia visible in the viewingwindow. One and two digit indicia 372 are formed on the top of theindicator member 360 such that a three digit number is indicated to theuser.

[0107] In yet another alternative embodiment shown in FIG. 3A, theviewing window 534 is formed in an upper portion of the downwardlydepending circumferential skirt 592 of the cap member. The indicia areapplied to the outer circumferential surface of the indicator memberskirt 574 so as to be visible through the window. In this embodiment, arim 542 of the base member is preferably scalloped in alignment with theviewing window 534 to provide an unobstructed view of the indicia and toinform the user as to the location of the viewing window.

[0108] One of the skill in the art should understand that other indiciaindicating the number of doses remaining in or dispensed from thecontainer would include, but not be limited to, various alpha-numericalcharacters, words, terms or phrases (such as “full” and “empty”),scales, grids, arrows, raised portions, indentations, color coding andsegmentation, shading and like markings, or any combination thereof. Forexample, a segmented color grid 172 displayed in the viewing window (asshown, e.g., in FIG. 1B) could turn from green, indicating a fullcontainer, to yellow, indicating an intermediate capacity, and finallyto red, indicating an empty container. It should also be understood thatthe indicia can be formed integrally with the counter member, or appliedthereto by means of paint, dye, etching, pad printing, hot stamping oradhesive labels. When using numerical indicia, the numbers can bearranged to go from 0 (or some beginning number) to the predeterminednumber of available doses such that a display of that number to the userindicates that the container is empty, or, conversely, to go from thestarting predetermined number to 0 (or some ending number), which againindicates to the user that the container is empty.

[0109] In a preferred embodiment, the indicator member is made ofacrylonitrile butadiene styrene (“ABS”), which is receptive to certainalternative processes of printing or applying the indicia, including padprinting and hot stamping. The cap member and base member are preferablymade of a hard plastic material such as Acetel.

[0110] Referring to FIGS. 5-9 and 12-18, a drive mechanism is shown asincluding a drive assembly. The drive assembly includes a ratchet wheel82 coaxially mounted to a drive member 86 on an axle 84. The ratchetwheel, drive member and axle can be made separately, with the ratchetwheel and drive member then mounted on the axle, or all three parts canbe integrally molded as a one-piece component. The drive assembly ispreferably made of hard plastic material such as Acetel.

[0111] In an alternative embodiment, shown in FIGS. 38 and 42, the driveassembly further includes a second dosage indicator member 1800coaxially mounted with and between the drive member 86 and ratchet wheel82. The indicator member 1800 is configured as a wheel and preferablyincludes dosage indicia positioned around the peripheral surface 1802thereof. Preferably, the indicia are comprised of consecutive numeralsrunning from 0 to 9.

[0112] In yet another alternative embodiment, shown in FIG. 44, thedrive assembly includes a ratchet wheel 82 coaxially mounted with anindicator member 1800. The drive member 86 is formed separately from theratchet wheel and indicator member and includes a single tooth 89 thatis dimensioned to be received in a groove 1801 formed in a collar 1082extending axially from the indicator member 1800. The tooth 89 of thedrive member 86 is received in the groove 1801 of the collar and can bemoved axially with respect to the collar, ratchet wheel and indicatormember.

[0113] The ratchet wheel 82 includes a plurality of teeth 88 (preferablyten) formed around its periphery. Each of the teeth includes anengagement surface 89 and a tapered surface 87. As noted above, thedrive member 86, whether integrally formed with the ratchet wheel orseparately connected thereto, includes a single tooth 89 extendingradially from the axle 84, or drive member collar.

[0114] In the embodiments shown in FIGS. 5, 6 and 45, the drive assemblyis mounted to the cap member by engaging opposite ends of the axle 84with downwardly extending hub portions 36, 236, 2236 such that the axle,ratchet wheel and drive member rotate about an axis substantiallyperpendicular to the axial movement of the cap member relative to thebase member and to the axis of rotation of the indicator member.Alternatively, the drive assembly can be mounted to the base member in asimilar manner.

[0115] Alternatively, as shown in the embodiment of FIGS. 38-39, theaxle 84 is received in a single hub 1036, or flexible snap enclosurerib. In this embodiment, the drive assembly further includes a ramp1083, which ramps up to a plurality of radially extending teeth 1085formed around the rotational axis of the drive assembly. A largerdiameter axle 1084 extends outwardly from the teeth. A reset member 1106includes a grippable wheel portion 1107 and a collar 1109 that isdimensioned to be received in an laterally facing opening 1302 formed inthe skirt of the cap member. A bearing support 1300 is formed around theperiphery of the opening so as to provide support for the collar. Thereset member 1106 further includes four flexible, resilient fingers 1304extending axially from the collar 1109. Each finger 1304 includes anengagement portion 1306 extending radially inward from the end of thefinger. The engagement portion is shaped to engage one of the teeth 1085formed on the drive assembly. A protrusion 1308, or rib, is formed onone of the fingers so as to extend radially outward therefrom. Theprotrusion 1308 acts as a drive portion and engages a downwardlydepending protrusion 1310 formed on the bottom of the indicator memberadjacent the gap 1061 formed between the teeth on the indicator member,as shown in FIG. 40. Preferably, the protrusion 1310 is positioned so asto be at the angular midpoint between the two teeth spanning the gap.

[0116] As shown in FIGS. 12-15, the drive mechanism further includes apawl member 48, shown as a flexible rod or finger, which extendsupwardly from the bottom portion of the base member and selectivelyengages one of the teeth of the ratchet wheel. Alternatively, the pawlmember can be moveably secured to the cap member and extend through thebase member to engage the top of the container, such that the axialmovement of the cap member toward the container causes the pawl to movetoward the ratchet wheel and engage one of the teeth thereon asdescribed below. A non-return member 238, also shown as a flexible rodor finger, extends downwardly from the top portion of the cap member andselectively engages another of the teeth 88 of the ratchet wheel. Itshould be understood that the pawl member could alternatively extendfrom the cap member (and the non-return member from the base member)when the drive assembly is mounted to the base member, as describedabove.

[0117] In operation, as shown in FIGS. 12-21, the user depresses the cap220 member from a fully extended position (see FIG. 12) toward the basemember such that the cap member bottoms out in the base member at thebottom of the stroke (FIG. 14) and such that the base member imparts anaxial load on the container until a metered dosage is dispensedtherefrom. In a preferred embodiment, the biasing force of the spring100 (shown in FIG. 6), or alternative return mechanism such as theresilient arm members which act as springs, is less than the biasingforce of the spring located in the metering valve of the container, suchthat the cap member first bottoms out in the base member with thecontainer then being moved downwardly in the housing until a metereddose is dispensed.

[0118] Referring to FIGS. 12, 13 and 14, as the cap member 220 isdepressed toward the base member 40, the pawl 48 selectively engages theengagement surface 89 of one of the ratchet wheel teeth and rotates theratchet wheel. The tapered surface 87 of one of the teeth formed on theratchet wheel simultaneously biases the non-return member 238 outwardlyuntil it selectively engages the next tooth near the bottom of thestroke. The user then releases the cap member whereinafter the spring100 (shown in FIG. 6), or similar return mechanism, biases the capmember 220 away from the base member 40 until the engagement memberengages the base portion at the top of the stroke as shown in FIG. 15.When the cap member is released by the user, the container is biasedupwardly within the housing along the longitudinal axis such that thevalve stem is moved to the closed position within the container.Simultaneously, as the cap member is released and allowed to move awayfrom the base member, the pawl 48 is biased outwardly by the taperedsurface 87 of one of the teeth on the ratchet wheel as the non-returnmember 238 prevents a backwards rotation thereof so as to maintain aunidirectional rotation of the ratchet wheel. At the top of the stroke(shown in FIG. 15), the pawl 48 is again placed in position forselective engagement with one of the teeth of the ratchet wheel. In thisway, the ratchet wheel 82, and connected drive member 86 (shown in FIGS.18-21), are advanced an incremental amount for every actuation of thecontainer and the attendant release of medicament. The incrementalamount is defined by and dependent on the number of teeth formed aboutthe periphery of the ratchet wheel. When formed with ten teeth, as shownin the preferred embodiment, the ratchet wheel will make one fullrevolution for every ten actuations of the indicator device andcontainer, or a tenth of a revolution for each actuation. One skilled inthe art will appreciate that the ratchet wheel can be provided withvarious numbers of teeth formed about its periphery such that the moreor less axial movements or actuations of the container are required tomake one full rotation of the ratchet wheel.

[0119] Alternatively, the operation of the ratchet wheel can bereversed. In this embodiment, the pawl is biased outwardly by thetapered surface of one of the ratchet wheel teeth on the downstroke. Atthe bottom of the stroke, the pawl is biased into engagement with one ofthe teeth. When the cap member is released by the patient, the spring,or equivalent return mechanism, biases the cap member upwardly withinthe base member along the longitudinal axis such that the pawl memberengages one of the teeth and thereby rotates the ratchet wheel anincremental amount. In this embodiment, the non-return member maintainsthe rotational position of the ratchet wheel on the downstroke.

[0120] As shown in FIGS. 18-20, 38 and 44 the drive member 86 is shownas preferably having a single tooth 89 or segment. Therefore, upon everytenth actuation, the drive member 86 is rotated such that the toothselectively engages one of the teeth 266 formed on the indicator memberso as to rotate the indicator member an incremental amount. Theincremental amount of rotation is defined by the distance betweenadjacent teeth, otherwise defined as the circular pitch of the teeth. Inthis way, the drive member is selectively engaged with at least one ofthe teeth of the indicator member after and upon a predetermined numberof axial movements of the cap member relative to the base member so asto rotate the indicator member the incremental amount. The predeterminedof number axial movements required to cause the indicator member torotate is defined by and dependent upon the reduction ratio of theratchet wheel and drive member, which, in turn, is defined by dividingthe number of teeth formed on the ratchet wheel by the number of teethformed on the drive member. For example, as shown in the preferredembodiment, a ratchet wheel having ten teeth and a drive member havingone tooth will result in an incremental movement of the indicatormember, otherwise defined as the advancement of one tooth of theindicator member, upon every ten axial movements. Similarly, if thedrive member had four teeth, and the ratchet wheel twenty, thepredetermined number would equate to five axial movements, and so on. Aone-to-one gear ratio would result in a predetermined number of oneaxial movement, wherein the indicator member would be moved upon everyaxial movement.

[0121] Referring to FIG. 19, the indicator member 260 and drive member86 are shown prior to an initial actuation or use by the user. Inparticular, the drive member tooth is positioned adjacent the firsttooth 266 on the indicator member. In this embodiment, wherein theratchet wheel comprises ten teeth, ten actuations are required beforethe tooth 89 engages the first tooth 266 on the indicator member asshown in FIG. 21. At this point, the indicator has completed a singlecycle equal to the number of predetermined number of axial movements,which results or culminates in the incremental movement of the indicatormember. The cycle is then repeated (by again making the predeterminednumber of axial movements) so as to again culminate in the incrementalmovement of the indicator member. Preferably, as shown in FIGS. 1A, 3A,24 and 26, numerical indicia (including numbers and dots) are applied inincrements of ten to correlate to the preferred embodiment requiring tenaxial movements for one incremental advancement of the indicator wheel.

[0122] The ratchet wheel and drive member with their reduction ratioprovide a simple but reliable mechanism for advancing the indicatormember. In particular, the indicator member can be made with fewer teeththan if it were required to advance upon every actuation of theindicator member and container. For ease of manufacturing, it isdesirable to provide as coarse a pitch on each of the indicator memberand ratchet wheel as possible, although the gears are still defined asfine-toothed gears. However, it is also intended that the indicatormember make only a single revolution (single-cycle) corresponding to acomplete evacuation of medicament from the container. Thus, when a largenumber of doses (on the order of 200 or more) are contained within thecontainer, it is important for the ratchet wheel and drive member toprovide a relatively high reduction ratio, such that 200 linearreciprocal movements of the cap member and container correspond to oneor less revolutions of the indicator member. As such, the indicatormember can be made with coarser teeth at less cost. In addition, largercoarser teeth interacting with a relatively large drive member toothhelps to improve the accuracy of the device as those parts mesh. Inaddition, the mechanism, and its attendant reduction ratio, permits theindicator member to make only a single revolution during the life of thecontainer, i.e., until it is emptied, even when the container contains arelatively large number of metered doses (on the order of 200 or moredoses). This single revolution corresponds to a usage cycle, which isdefined as the movement of the dosage indicator from an initial reading,which indicates that the container is full, to a final reading, whichindicates that the container is empty. Of course, the indicator member,if initially set to a smaller number of dosages, may make less than acomplete revolution in completing a usage cycle.

[0123] In the alternative embodiments shown in FIGS. 38 and 44, theviewing window 1034, 2034 is large enough such that the first and seconddosage indicator members 1060, 2060, 1800 with their indicia are visibletherein. In the operation of these embodiments, the indicator member1800 rotates with each actuation of the cap member 1020, 2020 relativeto the base member 1040, 2040 as the ratchet wheel 82 is driven by thepawl member. The indicator member 1800 rotates about an axissubstantially perpendicular to the axial movement of the cap memberrelative to the base member and to the rotational axis of the indicatormember 1060, 2060. In the preferred embodiment, with the indicatormember 1800 having “ones” indicia and the ratchet wheel 82 having tenteeth, the indicator member 1800 is advanced upon each actuation andprovides indicia visible to the user to notify them of such advancement.As the indicator member 1800 completes a cycle, or rotation, theindicator member 1060, 2060 is advanced one increment by the drivemember 86 and the indicator member 1800 begins another cycle. In thisway, the user is advised as to each actuation of the indicating deviceand the attendant dispensment of a dosage from the attached container.

[0124] Where, as shown in FIGS. 5 and 40, the teeth 66, 1066 extend onlypartially around the periphery of the indicator member, the indicatormember 60 1060 is not advanced after the drive member engages the lasttooth, even when the cap member is repeatedly moved to actuate thecontainer. This ensures that the indicator member cannot be advancedpast the last indicia indicating that the container is empty to a firstindicia indicating that the container is full, so as to confuse theuser.

[0125] Alternatively, as shown in FIGS. 33-36, the indicating deviceincludes a lock device. In particular, the base member includes a firstlock member 702, configured as a post member extending upwardly from thebottom of the base member. The indicator member 760 includes a secondlock member 704, shown in FIG. 35 as an extension of one of theplurality of teeth 776 formed around the circumference of the indicatormember. In operation, the cap member is moved towards and away from thebase member as described above so as to rotate the indicator member.During this operation, as shown in FIGS. 33 and 34, the first lockmember 702 is positioned inside the inner diametrical surface of theplurality of teeth so as to not interfere therewith as it is moved intothe recess formed by the indicator member as shown in FIG. 33. After theindicator member has made one complete rotation, which preferablycorrelates to an emptying of the container, the second lock member 704is rotated over the first lock member 702 as shown in FIGS. 35 and 36.In this position, the cap member cannot be moved toward the base memberand the user is thereby prevented from further discharging, orattempting to discharge, an empty container. The immobility of the capmember also provides a secondary indicia that the container is empty.One of skill in the art should understand that the size and shape of thefirst and second lock members can be varied. For example, a post membermay extend from the cap member so as to engage a stepped surface in thebase member.

[0126] As shown in FIGS. 29 and 30, a reset wheel 106 is coaxiallymounted with the ratchet wheel 82 and drive member 86. The outerperiphery 108 of the wheel, which includes a plurality of teeth forgripping by the user's thumb, is exposed as it extends through thebottom surface 50 of the base member. One of skill in the art shouldunderstand that the reset wheel can be exposed by extending from otherportions of the indicator device for access by the user. The userrotates the reset wheel 106 to manually rotate the indicator member toits original starting position, or any other desired setting, withouthaving to move the cap member relative to the base member. In this way,the indicator member can be recycled for use on a new container, or canbe moved to the proper setting prior to installing the indicating deviceon the container. In this way, the same indicating device can be usedwith various containers containing varying numbers of metered dosages ofmedicament.

[0127] During the movement of the indicator wheel relative to the capmember, the force of the indexing member against the indentations in oneof the cap member and indicator member is overcome such that theindexing member repeatedly moves into and out of engagement with theindentations as the indicator member is rotated by the user to thedesired setting. This movement is similar to the movement of theindexing member occurring upon each incremental advancement of theindicator member relative to the cap member.

[0128] Preferably, the reset wheel of FIGS. 29 and 30 is used with anindicator member having teeth formed about its entire periphery, suchthat the indicator wheel need only be moved a few teeth (one or more) toreturn it to the zero (or full, e.g., 200) position. The reset wheel canbe used with or without the lock device described above, since the wheelcan be used to move or rotate the indicator wheel independent of anyaxial movement between the cap member and base member.

[0129] In an alternative embodiment shown in FIG. 28, a reset selectormember 602 is mounted to the end of the axle and is exposed in anopening 604 in the side or skirt 694 of the base member. The resetselector member 602 is mounted on the axle. The selector member 602 isprovided with a slot adapted to receive the head of a screw driver orlike tool, which can be actuated by the user to rotate the axle,coaxially mounted drive member and indicator member until the desiredindicia are visible in the viewing window. This feature can be valuablefor resetting an indicating device for use on a new container, or forinitially setting the device for the proper number of doses contained inthe container. One of skill in the art should understand that recessesand/or protrusions other than the disclosed slot can be exposed on theselector member to allow the user to grip or otherwise operably engagethe selector member and to thereafter rotate the indicator member. Oneof skill in the art should also understand that the opening in the basemember could be positioned anywhere along the longitudinal path of theaxle as the cap member moves relative to the base member so as to exposethe selector member when aligned with the opening.

[0130] In yet another alternative embodiment, shown in FIG. 27, aselector window 806 is formed in the top of the cap member. A resetselector member 802, configured as a protrusion or like grippablemember, is exposed in the window as the indicator member is rotated tothe empty position. In one embodiment, as described above, the pluralityof teeth are formed only around a portion of the periphery of theindicator member so as to leave a gap between the first and last tooth.In such an embodiment, the selector window 806 is preferably of suchlength that the user can move the reset selector member 802 within thewindow until the first tooth is again in position for engagement withthe drive member. It should be understood, however, that the resetselector member can also be used with an indicator member having teethformed around the entire periphery of the member.

[0131] In an alternative embodiment, a plurality of reset members, or asimilar grippable surface, configured for example as a plurality ofnotches or teeth, can be formed around the entire periphery of theindicator member and exposed in a selector window, or alternatively, inthe viewing window. In such an embodiment, the indicator wheel can berotated to expose different indicia at any time simply by engaging thereset selector members on the indicator member with the user's thumb orlike member.

[0132] In yet another embodiment, shown in FIG. 24, an opening, orselector window 906, is provided in the top of the cap member. A thintool, such as a paper clip, is inserted through the opening to bias theresilient indexing member 370 out of engagement with the indicatormember. The user can then operably engage the indicator member withtheir finger or the like, either through the viewing window or aselector window, to move the indicator member to the desired setting.

[0133] In yet another alternative embodiment, shown in FIG. 43, thereset member, with the collar 1109 disposed on the axle 1084 of thedrive assembly, is pulled axially outward with respect thereto from adisengaged position, where the engagement portions 1306 of the flexiblefingers 1304 are positioned circumferentially around the axle 84, to anengaged reset position, such that the engagement portions 1306 of theflexible fingers are biased outwardly as they ride up the ramp 1083 andare thereafter moved into engagement with the teeth 1085 formed aroundthe axle of the drive assembly. The user then rotates the reset member1106 about a rotation axis, which is substantially perpendicular to theaxial movement of the cap member relative to the base member. As thereset member is rotated, the protrusion 1308 on the flexible fingers isbrought into engagement with the protrusion 1310 on the indicator member1060 so as to rotate the indicator member an incremental amount andthereby bring the first tooth on the other side of the gap 1061 intoposition for engagement by the drive member, thus bridging the gap 1061between the teeth of the indicator member. As the reset member 1106 isfurther rotated, the drive member tooth 89 engages the teeth 1066 of theindicator member, and the reset member can be rotated to manually drivethe indicator member, or indicator members, to the desired presetcondition. For example, the indicator members can be reset to indicate200 dosages for use with a container having 200 dosages.

[0134] In a preferred embodiment, the engagement portions 1306 and/orteeth 1085 formed on the axle of the drive assembly are configured toallow rotation of the drive member in only one direction. Therefore,rotation of the reset wheel in an opposite direction will not effect arotation of the drive member in that same direction as the flexiblefingers, with their engagement portions, will simply slide over theteeth formed about the axle. This one-way rotation prevents the drivemember from engaging and rotating the indicator member in an oppositedirection, which direction is opposed both by the non-return memberengaging the ratchet wheel, and the one-way indexing interface betweenthe cap member and indicator member.

[0135] To install the reset member and drive assembly, the driveassembly is installed in a vertical manner such that the axle 84 isreceived in the flexible snap enclosure 1036. Once the drive assembly issnapped in place, the reset member 1106 is inserted through the openingin the cap member and over the axle 1084 until the fingers eventuallyare disposed around the axle 84 in the disengaged position. In this way,the reset member, which is supported by the bearing surface 1300 of thecap member, further supports the drive assembly.

[0136] In yet another embodiment, best shown in FIGS. 52-55, theindicator member 2060 has a plurality of teeth extending around theentire circumference thereof. At least one of the teeth 2067 has acut-away portion 2069 aligned with the tooth 89 of the drive member.Accordingly, at the end of a cycle, the drive member is positioned in adisengaged position where even repetitive actuations of the indicatingdevice do not lead to the advancement of the indicator member as thedrive member, with its one or more teeth 89, merely passes through thecut-away portion 2069 of the tooth, with which it is aligned. In thisembodiment, however, the drive member 86 is axially moveable withrespect to the indicator member 1800 and ratchet wheel 82.

[0137] As best shown in FIGS. 44, 47 and 52-56, a reset member 2106includes a grippable wheel 2107 connected to a drive shaft 2109. Asshown in the preferred embodiment of FIG. 47, the end of the drive shaftincludes a plurality of teeth 2306, that engage slots 2308 or openingsdimensioned to receive the teeth formed in one end of the drive member86. The drive member is installed on the shaft of the reset wheel suchthat the teeth 2306 formed on the end thereof engage the slots 2308formed in the drive member. The drive member is then inserted into thegroove 1801 of the collar 1082 extending from the indicator member.

[0138] In operation, the user pulls the reset member 1206 axiallyoutward so as to move axially the drive member 86 from a disengagedposition, where the drive member tooth 89, or teeth, is aligned with thecut-away portion 2069 of the tooth on the indicator member, to anengaged or reset position, where the drive member tooth is brought intoengagement with the portion 2067 of the tooth that is not cut-away. Inthe reset position, the user rotates the reset wheel 2107 and connecteddrive member 86 so as to advance the indicator member 2060, or indicatormembers, to the desired setting independent of the axial movement of thecap member relative to the base member. In the disengaged position, thereset wheel is recessed between a pair of tapered flanges formed aroundthe circumference of the base member.

[0139] As shown in FIGS. 44 and 52-56, the indicator member 2060includes a cover portion 2087 that extends radially inward from the topportion of the indicator member. The cover portion is brought intoalignment with the viewing window at the end of the usage cycle suchthat the indicator 1800, which can continue to be spun beneath the coverportion is not visible. Indicia, such as the number “0” or the words“end” or “empty” can be applied to the cover portion to inform the userthat the container is empty.

[0140] As shown in FIG. 38, the indicating device also includes a usageindicator member 1500. The indicator member 1500 is configured as a ringand is disposed around the skirt 1074 of the dosage indicator member1060 where it is trapped between the rim flange 1078 of the indicatormember and the bottom surface of the top of the cap member. In this way,the usage indicator member 1500 is supported by and is moveable aboutthe dosage indicator member 1060. The indicator member 1500 also isthereby rotatably mounted about an axis substantially parallel to theaxial movement of the cap member relative to the base member. Theindicator member 1500, which is configured as a ring, has a plurality ofteeth 1502 formed around the outwardly facing radial periphery thereof.As the indicator member 1500 is advanced as explained above, a flexiblefinger 1273 formed along the circumferential rim 1078 of the indicatormember 1060 is biased radially inward by a ramp 1277 formed on theinside of the cap member so as to engage at least one of the pluralityof teeth 1502 formed on the indicator member and thereby advance theindicator member an incremental amount, defined by the distance betweenadjacent teeth. The number of teeth formed around the indicator membercorresponds to the number of intended usage cycles of the indicatingdevice.

[0141] In the preferred embodiment, which has only a single ramp 1277,the usage indicator member 1500 is advanced one tooth upon each completerotation of the dosage indicator member 1060, which corresponds to onecomplete usage cycle for the indicating device. For example, theindicating device can be initially set to reveal an initial count of 200dosages. As the indicating device is successively actuated to dispensethe dosages, the indicator members 1060, 1800, with indicia, areactuated to count down until they reveal a final count of 0 dosagesavailable for use. At that time, the drive assembly is positioned in thedisengaged position, as explained above.

[0142] As the reset member 1106 is used to actuate the drive assembly toreset the device for another usage cycle, the indicator member 1060 withits resilient finger 1273 is biased into engagement by the ramp 1277such that the usage indicator member is rotated. In this way, the usageindicator member 1500 is rotated, or advanced, upon the completion ofeach successive usage cycle. The number of teeth 1502 on the indicatormember 1500 corresponds to the number of intended uses for theindicator. For example, in the embodiment shown in FIGS. 38 and 41, theindicator member 1500 has twelve teeth corresponding to an intendedtwelve uses of the indicating device with twelve different containers.As noted above, the reset member can be used to reset the indicia at anydesired reading, such that one indicating device can be used withsuccessive containers having different numbers of dosages containedtherein. The indicator member 1500 also includes a stop member 1506formed as a protrusion that extends radially inward from the top of theindicator member. The stop member 1506 engages a stop member 1508extending downwardly from the top portion of the cap member uponcompletion of the final usage cycle. This engagement prevents the userfrom attempting to advance the dosage indicator member 1060 by way ofthe reset member and drive assembly, because the finger 1273 is biasedinto engagement with at least one of the teeth on the usage indicatormember, which is immobilized. In this way, the entire device isimmobilized. It should be understood that although the preferredembodiment is configured for twelve usage cycles, the usage indicatormember could be provided with more or less teeth corresponding to moreor less total available usage cycles.

[0143] Referring to FIG. 41, the usage indicator member 1500 furtherincludes an indexing member 1510 configured as a protrusion extendingradially outward from the outer circumferential surface of the indicatormember. The indexing member 1510 selectively engages a plurality ofteeth 1512 formed around the inner circumferential surface of the skirtof the cap member. The indexing member 1510 and teeth 1512 areconfigured as a ratchet to allow one-way rotation of the indicatormember 1500 relative to the cap member 1020. In a preferred embodiment,the indexing member and teeth are tapered to interact and provide forthe one-way action.

[0144] As shown in FIGS. 37 and 38, a plurality of viewing windows 1600are arranged around the outer periphery of the top of the cap member. Aplurality of indicia 1602, shown as successive numbers, are affixed tothe top of the cap member adjacent the viewing windows. The upper edge1514 of the usage indicator member is provided with indicia that isvisible through the viewing windows 1600, such that the user canascertain which usage cycle the indicating device is currentlyfunctioning in. For example, in the embodiment shown in FIGS. 37 and 38,twelve viewing windows 1600 are provided with the numbers 1 to 12arranged adjacent thereto, which correspond to the 12 usage cyclesdefining the life of the indicating device. The numbers, or otherindicia such as various colors, can be applied to the cap member byprinting, molding or any other of the techniques described above.Alternatively, a single viewing window can be provided to expose theindicator member, whereupon indicia can be applied to the top surface orupper edge 1514 thereof, or, if the window is provided in the side ofthe cap member, along the outer circumferential surface thereof.

[0145] In the embodiment shown in FIGS. 4445 and 49-51, the usageindicator member 2500 includes a hub 2520 having an opening 2521 that isrotatably mounted on a post 2522 extending downwardly from the innersurface of the top portion of the cap member 2020. In this way, theusage indicator member 2500 is rotatably mounted to the cap member 2020about an axis substantially parallel to and spaced from the rotationalaxis of the dosage indicator member 2060. The axis of rotation for thedosage usage indicator member is also substantially parallel to theaxial movement of the cap member relative to the base member.

[0146] The indicator member 2500 includes a ring 2524 formed about thehub 2520 which is connected thereto with a rib 2526 and a bottom surface2528. The indicator member 2500 has a plurality of inwardly, radiallyextending teeth 2514 formed about the inner periphery of the ring, and aplurality of outwardly, radially extending teeth 2502 formed on thebottom surface of the indicator member around the outer peripherythereof. Both pluralities of teeth are configured as ratchet teeth toallow only for one-way rotation of the indicator member 2500.

[0147] Referring to FIG. 46, an engagement member 2573 extends from theindicator member 2060 and engages an engagement surface of one of theratchet teeth 2502 as the dosage indicator member 2060 completes onefull cycle. As the engagement member 2573 engages the engagement surfaceof one of the teeth 2502, the indicator member is rotated an incrementalamount.

[0148] Referring to FIG. 51, an indexing member 2577 extends downwardlyfrom the cap member 2020 in a parallel and spaced apart relationshipwith the post 2522. The indexing member 2577 is disposed in the spacebetween the hub 2520 and the ring 2524 and selectively engages the innerteeth 2514 formed around the inner periphery of the ring. Again, theindexing member 2577 and teeth 2514 are preferably configured to allowfor only one-way rotation of the usage indicator member 2500 relative tothe cap member 2020. The number and angular spacing between the innerand outer teeth 2514, 2502 correspond such that the advancement of theindicator member 2500 by way of engagement of the engagement member 2573with one of the outer 2502 teeth further advances the indexing member2577 one tooth 2514 along the inner periphery of the ring. Thepredetermined number of usages for the indicating device corresponds tothe number of teeth formed around the inner periphery of the ring. Afterthe completion of the final usage cycle, the indexing member 2577 isbrought into engagement with the rib 2526, which functions as a stopmember and does not permit the indicator member to be further rotated oradvanced. At the same time, the engagement member 2573 is brought intoengagement with one of the teeth 2502 formed about the outer peripheryof the ring such that the indicator member also cannot be advanced. Inthis way, the device is immobilized. Again, the indicating device can beprovided with a predetermined number of inner and outer teeth, whichcorresponds to the number of predetermined usage cycles for theindicating device.

[0149] The upper surface 2528 of the indicator member ring, which ispreferably domed, is provided with usage indicia to indicate the numberof usage cycles completed or remaining for the indicating device. Theusage indicia is visible to the user through a viewing window 2600provided in the cap member, as shown in FIG. 44. Again, the usageindicia can take the form of various alphanumeric characters, colors orany of the other varieties described above.

[0150] Although the present invention has been described with referenceto preferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

What is claimed is:
 1. An indicating device suitable for indicating thenumber of metered dosages that have been dispensed from or remain in acontainer, said indicating device comprising: a base member adapted tobe mounted to the container; a cap member moveably connected to saidbase member, said cap member moveable relative to said base member alongan axial path; an indicator member rotatably mounted to said cap memberabout an axis substantially parallel to the axial movement of said capmember relative to said base member; and a drive member rotatablymounted to one of said cap member and said base member about an axissubstantially perpendicular to the rotational axis of said indicatormember and wherein said drive member is selectively engaged with saidindicator member upon a predetermined number of axial movements of saidcap member relative to said base member so as to rotate said indicatormember an incremental amount relative to said cap member.
 2. Theindicating device of claim 1 further comprising a ratchet wheelcoaxially mounted with said drive member and a pawl connected to one ofsaid base member and said cap member, said pawl selectively engaged withsaid ratchet wheel upon each said axial movement of said cap memberrelative to said base member so as to rotate said ratchet wheel and saiddrive member an incremental amount.
 3. The indicating device of claim 2wherein said ratchet wheel and said drive member are rotatably mountedto said cap member, and wherein said pawl is connected to said basemember.
 4. The indicating device of claim 2 further comprising anon-return member attached to one of said cap member and said basemember, said non-return member adapted to selectively engage saidratchet wheel so as to maintain a unidirectional rotation of saidratchet wheel.
 5. The indicating device of claim 1 wherein saidindicator member comprises a plurality of teeth and said drive membercomprises a single tooth, said drive member selectively engaged with atleast one of said plurality of teeth on said indicator member once uponevery complete rotation of said drive member, whereby said indicatormember is moved said incremental amount once upon every completerotation of said drive member, said complete rotation accomplished bymaking said predetermined number of axial movements of said cap memberrelative to said base member.
 6. The indicating device of claim 1wherein said incremental amount of movement of said indicator membercorresponds to the pitch of said plurality of teeth on said indicatormember.
 7. The indicating device of claim 5 further comprising a ratchetwheel connected to said drive member, said ratchet wheel comprising tenteeth, whereby said drive member makes said complete rotation and saidindicator member is moved said incremental amount upon every ten axialmovements of said cap member relative to said base member.
 8. Theindicating device of claim 1 further comprising a return mechanismdisposed between said cap member and said base member, said returnmechanism biasing said cap member away from said base member.
 9. Theindicating device of claim 8 wherein said return mechanism comprises aspring.
 10. The indicating device of claim 9 wherein said returnmechanism comprises at least one resilient arm member extending from oneof said cap member and said base member and engaging the other of saidcap member and said base member.
 11. The indicating device of claim 1wherein said cap member is moveable between an extended position and adepressed position relative to said base member, and wherein one of saidcap member and said base member comprises at least one engagementmember, said engagement member engaging the other of said cap member andsaid base member when cap member is in said extended position relativeto said base member so as to moveably connect said cap member and saidbase member and thereby prevent separation therebetween.
 12. Theindicating device of claim 11 wherein said engagement member axiallyengages the other of said cap member and said base member so as toprevent axial separation therebetween.
 13. The indicating device ofclaim 1 wherein one of said cap member and said indicator member furthercomprises a plurality of indentations, and the other of said cap memberand said indicator member comprises at least one indexing member, saidindexing member selectively engaged with at least one of saidindentations so as to prevent rotation of said cap member relative tosaid indicator member when said indicator member is not beingselectively engaged by said drive member and rotated said incrementalamount relative to said cap member.
 14. The indicating device of claim13 wherein the angular distance between adjacent indentations issubstantially the same as the angular distance between the plurality ofteeth on the indicator member, whereby said indexing member selectivelyengages at least one of said indentations after said indicator membermoves said incremental amount relative to said cap member.
 15. Theindicating device of claim 1 further comprising a reset wheel coaxiallymounted with said drive member, said reset wheel adapted to be operablyengaged by a user to rotate said drive member and thereby selectivelyengage and rotate said indicator member to a desired setting.
 16. Theindicating device of claim 1 wherein a portion of said indicator memberis exposed to a user whereby the user can rotate said indicator memberto a desired setting.
 17. The indicating device of claim 1 wherein saidcap member further comprises a viewing window and said indicator membercomprises dosage indicia visible to a user through said viewing window.18. The indicating device of claim 1 further comprising an adaptermember connected to said base member, said adapter member adapted toengage said container.
 19. The indicating device of claim 1 wherein oneof said cap member and said base member comprise a key hole, and theother of said cap member and said base member comprise a key member,said key hole shaped to receive said key member so as to preventrotation between said cap member and said base member.
 20. An inhalationdevice for dispensing metered dosages of medicaments from a containercomprising: a housing having a longitudinally extending cavity and awell located at a bottom of said cavity, said housing having a generallyopen end at a top of said cavity; said container comprising a valve stemextending longitudinally therefrom and moveable between a closedposition and an open position, said container containing a plurality ofmetered dosages of medicaments, said valve stem dispensing one of saidplurality of said metered dosages when said valve stem is moved to theopen position, said container disposed in said cavity of said housingsuch that said valve stem is received within said well and such that abottom end of said container extends from the generally open end of saidhousing so as to be exposed to the user, said container reciprocallymoveable within said housing along said longitudinal extent of thecavity such that said valve stem is moved between said open and closedposition by engagement with said well; and an indicating devicecomprising: a base member mounted to the bottom end of said containerextending from said generally open end of said housing; a cap membermoveably connected to said base member, said cap member moveablerelative to said base member along said longitudinal axis; an indicatormember rotatably mounted in said cap member about an axis substantiallyparallel to the longitudinal movement of said cap member relative tosaid base member and of said container relative to said housing, saidindicator member comprising a plurality of teeth; a drive mechanismcomprising a ratchet wheel rotatably mounted to one of said base memberand said cap member about an axis substantially perpendicular to thelongitudinal movement of said cap member relative to said base memberand of said container relative to said housing, a drive member coaxiallymounted with said ratchet wheel, and a pawl mounted on one of said basemember and said cap member, said pawl selectively engaged with saidratchet wheel upon each longitudinal movement of said cap memberrelative to said base member so as to rotate said ratchet wheel and saiddrive member an incremental amount, and wherein said drive member isselectively engaged with at least one of said plurality of saidindicator member teeth upon a predetermined number of longitudinal axialmovements of said cap member relative to said base member so as torotate said indicator member an incremental amount.
 21. The inhalationdevice of claim 20 wherein said ratchet wheel and said drive member arerotatably mounted to said cap member, and wherein said pawl is mountedto said base member.
 22. The inhalation device of claim 20 furthercomprising a non-return member attached to one of said cap member andsaid base member, said non-return member adapted to selectively engagesaid ratchet wheel so as to maintain a unidirectional rotation of saidratchet wheel.
 23. The inhalation device of claim 20 wherein said drivemember comprises a single tooth, said drive member selectively engagedwith said at least one of said plurality of teeth on said indicatormember once upon every complete rotation of said ratchet wheel, wherebysaid indicator member is moved said incremental amount once upon everycomplete rotation of said ratchet wheel, said complete rotationaccomplished by making said predetermined number of axial movements ofsaid cap member relative to said base member.
 24. The inhalation deviceof claim 20 further comprising a return mechanism disposed between saidcap member and said base member so as to bias said cap member away fromsaid base member.
 25. The inhalation device of claim 20 wherein said capmember is moveable between an extended position and a depressed positionrelative to said base member, and wherein one of said cap member andsaid base member comprises an engagement member, said engagement memberengaging the other of said cap member and said base member when said capmember is in said extended position relative to said base member so asto moveably connect said cap member and said base member and therebyprevent separation therebetween.
 26. The inhalation device of claim 20wherein one of said cap member and said indicator member furthercomprises a plurality of indentations, and the other of said cap memberand said indicator member comprises at least one indexing member, saidindexing member selectively engaged with at least one of saidindentations as to prevent rotation of said cap member relative to saidindicator member when said indicator member is not being selectivelyengaged by said drive member and rotated said incremental amountrelative to said cap member.
 27. The inhalation device of claim 26wherein the angular distance between adjacent indentations issubstantially the same as the angular distance between the plurality ofteeth on said indicator member, whereby said indexing member selectivelyengages at least one of said indentations after said indicator membermoves said incremental amount relative to said cap member.
 28. Theinhalation device of claim 20 further comprising a reset membercoaxially mounted with said ratchet wheel and said drive member, saidreset member adapted to be operably engaged by a user to rotate thedrive member and thereby selectively engage and rotate the indicatormember.
 29. The inhalation device of claim 20 wherein said cap memberfurther comprises a viewing window and said indicator member comprisesdosage indicia visible to a user through said viewing window.
 30. Theinhalation device of claim 20 further comprising an adapter memberconnected to said base member, said adapter member engaging said bottomend of said container.
 31. An indicating device for indicating thenumber of metered doses dispensed from or remaining in a container, saidindicating device comprising: a base member adapted to be mounted to thecontainer; a cap member moveably connected to said base member, said capmember axially moveable relative to said base member; an indicatormember rotatably mounted in said cap member about an axis substantiallyparallel to the axial movement of said cap member relative to said basemember; and a drive mechanism comprising a means responsive to saidaxial movement of said cap member relative to said base member forrotating said indicator member an incremental amount upon apredetermined number of said axial movements.
 32. An indicating devicefor indicating the number of metered doses dispensed from or remainingin a container, said indicating device comprising: a base member adaptedto be mounted to the container; a cap member moveably connected to saidbase member, said cap member moveable relative to said base member alongan axial path; an indicator member rotatably mounted to said cap member;and a mechanism selectively engaged between said cap member and saidindicator member wherein said mechanism rotates said indicator member anincremental amount upon a predetermined number of axial movements ofsaid cap member relative to said base member, wherein said predeterminednumber of axial movements is greater than one.
 33. The invention ofclaim 32 wherein said cap member comprises an engagement member, saidengagement member engaging said indicator member so as to prevent axialmovement between said indicator member and said cap member.
 34. Theinvention of claim 32 wherein said mechanism comprises a ratchet wheelrotatably mounted to said cap member and comprising a plurality ofteeth; a drive member rotatably mounted to said cap member andcomprising at least one tooth, wherein the number of plurality of teethon said ratchet wheel is greater than the number of said at least onetooth on the drive member; and a pawl member extending from said basemember, wherein said pawl member selectively engages said ratchet wheelupon each axial movement of said cap member relative to said basemember, said ratchet wheel rotatably engaged with said drive member, andsaid drive member selectively engaged with said indicator member uponsaid predetermined number of axial movements to rotate said indicatormember said incremental amount.
 35. The invention of claim 34 whereinsaid predetermined number of axial movements is determined by dividingthe number of said plurality of teeth on said ratchet wheel by thenumber of said at least one tooth on said drive member.
 36. Theinvention of claim 32 wherein said cap member comprises a viewing windowand said indicator member comprises indicia visible through said viewingwindow.
 37. The invention of claim 32 wherein one of said indicatormember and said cap member comprises a plurality of indentations and theother of said indicator member and said cap member comprises an indexingmember, said indexing member engaging at least one of said plurality ofsaid indentations.
 38. An indicating device for indicating the number ofmetered doses dispensed from or remaining in a container, saidindicating device comprising: a base member adapted to be mounted to thecontainer; a cap member moveably connected to said base member, said capmember moveable relative to said base member along an axial path; anindicator member disposed in said cap member; and an engagement memberdisposed on one of said indicator member and said cap member andengaging the other of said indicator member and said cap member so as toprevent axial movement between said cap member and said indicator memberand such that said indicator member is rotatably mounted to said capmember about an axis substantially parallel to the axial path defined bythe movement of said cap member relative to said base member.
 39. Theinvention of claim 38 further comprising a mechanism selectively engagedbetween said cap member and said indicator member wherein said mechanismrotates said indicator member an incremental amount upon a predeterminednumber of axial movements of said cap member relative to said basemember.
 40. The invention of claim 39 wherein said mechanism comprises aratchet wheel rotatably mounted to said cap member and comprising aplurality of teeth, a drive member rotatably mounted to said cap memberand comprising at least one tooth, and a pawl member extending from saidbase member, wherein said pawl member is selectively engaged with saidratchet wheel upon each axial movement of said cap member relative tosaid base member, said ratchet wheel rotatably engaged with said drivemember, and said drive member selectively engaged with said indicatormember upon said predetermined number of axial movements to rotate saidindicator member said incremental amount.
 41. An indicating device forindicating the number of metered dosages that have been dispensed fromor remain in a container, said indicating device comprising: a basemember adapted to be mounted to the container; a cap member moveablyconnected to said base member; an indicator member moveably mounted toone of said base member and said cap member; a drive member selectivelyengaged with said indicator member; and a reset member operablyconnected to said drive member, said reset member moveable relative tosaid cap member and operable to move said drive member and cause saidindicator member to move relative to said cap member independent of anymovement of said cap member relative to said base member.
 42. Theindicating device of claim 41 wherein said reset member is connected tosaid drive member, said reset member operable to move said drive memberinto selective engagement with said indicator member independent of saidaxial movement of said cap member relative to said base member.
 43. Theindicating device of claim 42 wherein said reset member is coaxiallymounted with said drive member.
 44. The indicating device of claim 43wherein said base member has an opening, and wherein said reset memberis exposed in said opening.
 45. The indicating device of claim 41wherein said reset member is 5 disposed on said indicator member, saidreset member exposed to the user for operable engagement by the user.46. The indicating device of claim 45 wherein said cap member has aselector window, said reset member exposed to a user in said selectorwindow.
 47. An indicating device for indicating the number of metereddosages that have been dispensed from or remain in a container, saidindicating device comprising: a base member adapted to be mounted to thecontainer; a cap member moveably connected to said base member; anindicator member moveably mounted to one of said base member and saidcap member, said indicator member moveable in response to apredetermined number of movements of said cap member relative to saidbase member; and means for moving said indicator member relative to saidcap member independent of said movement of said cap member relative tosaid base member, whereby said indicator member can be moved to adesired setting without moving the cap member relative to the basemember.
 48. The indicating device of claim 47 wherein said means formoving comprises a drive member selectively engaged with said indicatormember and a reset member connected to said drive member.
 49. Theindicating device of claim 47 wherein said means for moving comprises areset member disposed on said indicator member, said reset memberexposed to the user.
 50. A method for indicating the number of metereddosages of medicaments dispensed from or remaining in a container havinga valve stem extending longitudinally therefrom and moveable between aclosed position and an open position, said container dispensing saidmetered dosage when said valve stem is moved to the open position, saidmethod comprising the steps of: providing a housing having a well and anexhaust port, said well communicating with said exhaust port, saidhousing having a generally open end opposite said well; providing saidcontainer filled with a predetermined number of measured dosages, saidcontainer moveably supported in said housing along a longitudinal axis,said container comprising a valve stem received within said well of saidhousing and moveable between a closed and open position as saidcontainer is moved longitudinally within said housing, said containeradapted to discharge a measured dosage when said valve stem is moved tothe open position, said container having a bottom end extending from thegenerally open end of said housing; providing an indicating devicecomprising: a base member mounted to the bottom end of said containerextending from said generally open end of said housing; a cap membermoveably connected to said base member, said cap member moveablerelative to said base member along said longitudinal axis; an indicatormember rotatably mounted in said cap member about an axis substantiallyparallel to the longitudinal movement of said cap member relative tosaid base member and of said container relative to said housing, saidindicator member comprising a plurality of teeth; and a drive mechanismcomprising a ratchet wheel rotatably mounted to one of said base memberand said cap member about an axis substantially perpendicular to thelongitudinal movement of said cap member relative to said base memberand of said container relative to said housing, a drive member coaxiallymounted with said ratchet wheel, and a pawl mounted on one of said basemember and said cap member; moving said cap member towards said basemember so as to move said container along said longitudinal axis andthereby move said valve stem to the open position so as to discharge ameasured dosage through said well and said port; moving said cap memberaway from said base member; engaging said ratchet wheel with said pawlupon one of said steps of moving said cap member toward and away fromsaid base member so as to rotate said ratchet wheel and said drivemember; and engaging said indicator member with said drive member so asto rotate said indicator member.
 51. A method for indicating the numberof metered dosages of medicaments dispensed from or remaining in acontainer having a valve stem extending longitudinally therefrom andmoveable between a closed position and an open position, said containerdispensing said metered dosage when said valve stem is moved to the openposition, said method comprising the steps of: providing a housinghaving a well and an exhaust port, said well communicating with saidexhaust port, said housing having a generally open end opposite saidwell; providing said container filled with a predetermined number ofmeasured dosages, said container moveably supported in said housingalong a longitudinal axis, said container comprising a valve stemreceived within said well of said housing and moveable between a closedand open position as said container is moved longitudinally within saidhousing, said container adapted to discharge a measured dosage when saidvalve stem is moved to the open position, said container having a bottomend extending from the generally open end of said housing; providing anindicating device for indicating the number of metered doses that havebeen dispensed from a container, said indicating device comprising: abase member adapted to be mounted to the container; a cap membermoveably connected to said base member, said cap member moveablerelative to said base member along an axial path; an indicator memberrotatably mounted to said cap member; and a mechanism selectivelyengaged between said cap member and said indicator member wherein saidmechanism rotates said indicator member an incremental amount upon apredetermined number of axial movements of said cap member relative tosaid base member, wherein said predetermined number of axial movementsis greater than one; moving said cap member towards and away from saidbase member said predetermined number of axial movements; and engagingsaid indicator member with said mechanism upon reaching saidpredetermined number of axial movements so as to move said indicatormember said incremental amount.
 52. A method for assembling a device fordispensing metered dosages of medicaments from a container, said methodcomprising the steps of: providing a housing comprising a support blockand a wall spaced apart from said support block, said support blockhaving a well and an orifice communicating with said well; providingsaid container comprising a valve stem; inserting said valve stem ofsaid container into said well of said support block such that saidcontainer is disposed in said housing; providing an indicating devicecomprising: a base member; a cap member moveably connected to said basemember, said cap member moveable relative to said base member along alongitudinal axis; an indicator member rotatably mounted in said capmember about an axis substantially parallel to the longitudinal movementof said cap member relative to said base member; and a drive memberrotatably mounted to one of said base member and said cap member aboutan axis substantially perpendicular to the longitudinal movement of saidcap member relative to said base member, said drive member selectivelyengaged with said indicator member; and mounting said base member tosaid container.
 53. The method of claim 52 wherein said indicator devicefurther comprises a ratchet wheel coaxially mounted with said drivemember and a pawl mounted to one of said cap member and said basemember.
 54. A kit having components capable of being assembled as aninhalation device for dispensing metered dosages of medicaments from acontainer, the kit comprising: a housing having a longitudinallyextending cavity and a well located at a bottom of said cavity, saidhousing having a generally open end at a top of said cavity; saidcontainer comprising a valve stem extending longitudinally therefrom,said container containing a plurality of metered dosages of medicament,said valve stem adapted to be received in said well of said housing; andan indicating device comprising a base member adapted to be mounted tosaid container, a cap member moveably connected to said base member,wherein said cap member is moveable relative to said base member alongan axial path, an indicator member rotatably mounted to said cap memberabout an axis substantially parallel to the axial movement of said capmember relative to said base member, and a drive member rotatablymounted to one of said cap member and said base member about an axissubstantially perpendicular to the rotational axis of said indicatormember, wherein said drive member is selectively engaged with saidindicator member upon a predetermined number of axial movements of saidcap member relative to said base member, whereby said drive memberrotates said indicator member an incremental amount relative to said capmember upon said predetermined number of axial movements.
 55. A kithaving components capable of being assembled as an inhalation device fordispensing metered dosages of medicaments from a container, the kitcomprising: a housing having a longitudinally extending cavity and awell located at a bottom of said cavity, said housing having a generallyopen end at a top of said cavity; said container comprising a valve stemextending longitudinally therefrom, said container containing aplurality of metered dosages of medicament, said valve stem adapted tobe received in said well of said housing; and an indicating devicecomprising a base member adapted to be mounted to said container, a capmember moveably connected to said base member, wherein said cap memberis moveable relative to said base member along an axial path, anindicator member rotatably mounted to said cap member about an axissubstantially parallel to the axial movement of said cap member relativeto said base member, and a mechanism selectively engaged between saidcap member and said indicator member wherein said mechanism rotates saidindicator member an incremental amount upon a predetermined number ofaxial movements of said cap member relative to said base member, whereinsaid predetermined number of axial movements is greater than one.
 56. Anindicating device suitable for indicating the number of metered dosagesthat have been dispensed from or remain in a container, said indicatingdevice comprising: a base member adapted to be mounted to the container;a cap member moveably connected to said base member, said cap membermoveable relative to said base member along an axial path; a firstindicator member rotatably mounted to said cap member about an axissubstantially parallel to the axial movement of said cap member relativeto said base member; a second indicator member rotatably mounted to saidcap member about an axis substantially parallel to the axial movement ofsaid cap member relative to said base member; wherein said firstindicator member selectively engages said second indicator member uponcompletion of one usage cycle of said first indicator member so as torotate said second indicator member an incremental amount.
 57. Theindicating device of claim 56 wherein one of said first and secondindicator members comprises an engagement member and wherein the otherof said first and second indicator members comprises at least oneengagement surface shaped to engage said engagement member, wherein saidengagement member engages said engagement surface upon one completerotation of said first indicator member so as to rotate said secondindicator member an incremental amount.
 58. The indicating device ofclaim 57 wherein said cap member comprises a ramp portion, wherein saidramp portion biases said engagement member into selective engagementwith said engagement surface as said engagement member is rotated pastsaid ramp portion.
 59. The indicating device of claim 56 wherein saidsecond indicator member comprises a first stop portion and said capmember comprises a second stop portion, said first stop portion engagingsaid second stop portion after a predetermined number of completerotations of said first indicator member so as to immobilize said secondindicator member and said first indicator member as it is selectivelyengaged with said second indicator member.
 60. The indicating device ofclaim 56 wherein said axes of rotation for said first and secondindicator members are coaxial.
 61. The indicating device of claim 56wherein said axes of rotation for said first and second indicatormembers are spaced apart.
 62. The indicating device of claim 56 whereinsaid cap member comprises a first and second viewing window and whereinsaid first indicator member comprises dosage indicia visible to a userthrough said first viewing window and wherein said second indicatormembers comprises usage indicia visible to said user through said secondviewing window.
 63. The indicating device of claim 57 wherein saidsecond indicator member comprises a plurality of teeth formed thereon,each of said plurality of teeth comprising an engagement surface. 64.The indicating device of claim 56 wherein one of said second indicatormember and said cap member comprise an indexing member and the other ofsaid second indicator member and said cap member comprise a plurality ofindentations shaped to selectively engage said indexing member.
 65. Anindicating device suitable for indicating the number of metered dosagesthat have been dispensed from or remain in a container, said indicatingdevice comprising: a base member adapted to be mounted to the container;a cap member moveably connected to said base member, said cap membermoveable relative to said base member along an axial path; a firstindicator member rotatably mounted to said cap member about an axissubstantially parallel to the axial movement of said cap member relativeto said base member; a second indicator member rotatably mounted to oneof said cap member and said base member about an axis substantiallyperpendicular to the rotational axis of said first indicator member. 66.The indicating device of claim 65 further comprising a drive membercoaxially mounted with said second indicator member, said drive memberselectively engaged with said first indicator member upon apredetermined number of axial movements of said cap member relative tosaid base member so as to rotate said first indicator member anincremental amount relative to said cap member.
 67. The indicatingdevice of claim 66 further comprising a ratchet wheel coaxially mountedwith said drive member and said second indicator member, and a pawlconnected to the other of said base member and said cap member, saidpawl selectively engaged with said ratchet wheel upon each said axialmovement of said cap member relative to said base member so as to rotatesaid ratchet wheel, said drive member and second indicator member anincremental amount.
 68. The indicating device of claim 67 wherein saidratchet wheel, said drive member and said second indicator member arerotatably mounted to said cap member, and wherein said pawl is connectedto said base member.
 69. The indicating device of claim 65 furthercomprising a third indicator member rotatably mounted to said cap memberabout an axis substantially parallel to the axial movement of said capmember to said base member; wherein said first indicator memberselectively engages said third indicator member upon one completerotation of said first indicator member so as to rotate said thirdindicator member an incremental amount.
 70. The indicating device ofclaim 66 wherein said drive member is axially moveable with respect tosaid second indicator member.
 71. The indicating device of claim 70wherein said first indicator member comprises a plurality of teeth, saiddrive member selectively engaged with at least one of said teeth as saiddrive member rotates, and wherein at least one of said plurality ofteeth has a cut-away portion, said drive member axially moveable betweena disengaged position wherein said drive member is positioned in saidcut-away portion of said at least one of said teeth so as to avoidengagement therewith and an engaged reset position wherein said drivemember is positioned to selectively engage the portion of said at leastone of said plurality of teeth that is not cut-away.
 72. The indicatingdevice of claim 66 wherein said second indicator member comprises dosageindicia visible to a user, said second indicator member rotating inresponse to each axial movement of said cap member relative to said basemember.
 73. The indicating device of claim 72 wherein said firstindicator member comprises dosage indicia visible to the user, saiddosage indicia of said first and second indicator members in combinationindicating to the user the dosages remaining in or dispensed from thecontainer.
 74. The indicating device of claim 43 wherein said drivemember is moveable between a disengaged position where said drive memberis incapable of selectively engaging said indicator member and a resetposition where said drive member is positioned to selectively engagesaid indicator member.
 75. The indicating device of claim 43 whereinsaid reset member is axially moveable with respect to said drive member,said reset member moveable between a disengaged position wherein saidreset member is disengaged from said drive member and an engagedposition wherein said reset member is engaged with said drive member.76. The indicating device of claim 75 wherein said reset member furthercomprises a drive portion adapted to engage a protrusion formed on saidfirst indicator member when said reset member is positioned in saidengaged position, wherein said reset member is operable to be rotated tocause said drive portion to engage said protrusion and thereby rotatesaid indicator member, wherein said drive member is operable tothereafter engage said indicator member.
 77. An indicating devicesuitable for indicating the number of metered dosages that have beendispensed from or remain in a container, said indicating devicecomprising: an indicating device housing adapted to be mounted to thecontainer; a dosage indicator member disposed in said housing, saiddosage indicator member comprising dosage indicia visible to a userwhich indicate the number of dosages dispensed from or remaining in thecontainer; a usage indicator member disposed in said housing, said usageindicator member comprising usage indicia visible to the user whichindicate the number of usage cycles completed by or remaining for saidindicating device.